Daewoong Pharmaceutical Announces Phase 3 Clinical Trial Results of Diabetes New Drug 'Inavogliflozin'

At the Korean Diabetes Association International Conference
Results of Monotherapy, Dual Therapy, and Triple Therapy Released
Confirmed Blood Sugar Control Efficacy and Safety

Daewoong Pharmaceutical's 'Inavogliflozin' Phase 3 Clinical Trial Results Presentation. [Photo by Daewoong Pharmaceutical]

[Asia Economy Reporter Lee Gwan-joo] Daewoong Pharmaceutical announced on the 12th that it presented the Phase 3 clinical trial results of the new diabetes drug 'Inavogliflozin' at the International Congress of Diabetes and Metabolism (ICDM) held on the 7th and 8th.

Daewoong Pharmaceutical conducted Phase 3 clinical trials of Inavogliflozin as monotherapy, dual therapy combined with metformin, and triple therapy combined with metformin and gemigliptin for domestic product approval. The monotherapy trial involved 160 patients with type 2 diabetes whose blood glucose was not controlled by diet and exercise therapy; the dual therapy trial involved 200 patients with type 2 diabetes whose blood glucose was not controlled by metformin alone; and the triple therapy trial involved 270 patients with type 2 diabetes whose blood glucose was not controlled by metformin and gemigliptin.

All three trials confirmed the efficacy and safety of Inavogliflozin through 24 weeks of administration. The monotherapy trial was conducted as a placebo-controlled superiority trial, showing a statistically significant reduction of about 1 percentage point in glycated hemoglobin (HbA1c) compared to placebo. Significant improvements were also confirmed compared to placebo in weight, blood pressure, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).

In the dual therapy, non-inferiority was demonstrated in the change rate of glycated hemoglobin compared to the active comparator dapagliflozin, along with significant improvement in insulin resistance (HOMA-IR). From a safety perspective, significantly lower adverse drug reactions were observed, proving safety and tolerability. Additionally, the triple therapy trial also demonstrated non-inferiority in glycated hemoglobin change rate compared to the active comparator dapagliflozin.

Professor Kwak Soo-heon of Seoul National University Hospital’s Department of Endocrinology and Metabolism, the principal investigator of the monotherapy trial who presented the clinical results, stated, "Inavogliflozin showed superior blood glucose-lowering effects and safety compared to placebo in monotherapy trials targeting patients with type 2 diabetes," adding, "It is expected to be an effective treatment option that combines blood glucose-lowering effects with metabolic improvement in patients with type 2 diabetes who require monotherapy or combination therapy."

Inavogliflozin is a new diabetes drug in the sodium-glucose co-transporter-2 (SGLT-2) inhibitor class, developed for the first time domestically by Daewoong Pharmaceutical. SGLT-2 inhibitors selectively inhibit the SGLT-2 transporter located in the proximal tubules of the kidney, which is involved in glucose reabsorption, thereby reducing blood glucose by directly excreting glucose through urine. It was designated as the first fast-track drug in Korea in 2020, and Daewoong Pharmaceutical applied for product approval from the Ministry of Food and Drug Safety in March this year. The company aims to obtain approval within this year and launch the product domestically in the first half of next year.

Lee Chang-jae, CEO of Daewoong Pharmaceutical, said, "Daewoong Pharmaceutical is developing Inavogliflozin, which has excellent blood glucose-lowering effects, as the best-in-class drug in its category," and added, "By rapidly launching the next-generation diabetes drug Inavogliflozin, we hope to improve the quality of life for patients suffering from diabetes worldwide, including in Korea."

This content was produced with the assistance of AI translation services.